I had time to call Dr. Maldarelli this afternoon about the study the CAA announced. I first got his voice mail, but he returned my call quickly and spent about 1/2 hour on the phone with me, answering my variety of questions. No arrogance whatsoever, VERY kind and easy to converse with. I would have preferred a 2-3 hour conversation with him, of course, but kept my questions at this point to those of greatest concern to me.
My "report" of the conversation below is based on my understanding of his answers, not a verbatim transcript of what he said. And please don't construe anything below as an "official" NIH, NCI or BWG position on any topic -- this is just my understanding of what we discussed. For anyone who doesn't want to wade through it all, I've bolded what I think are the most important points.
The sample collection is not being "sponsored" by the BWG per se, but is related. The samples to be drawn for this study will be blinded and sent to the labs involved in the BWG, including Judy at WPI, Frank Ruscetti's group in Frederick and Lo/Alter, as well as others who are participating in the search for testing methods that are sensitive, specific and support high throughput. Again, the labs who will be testing the fresh samples will use their own preferred methods (me - aargh), to include serology as well as the various PCRs and other testing methods being developed or currently in use. Switzer at the CDC is also participating.
He said that the retrovirologists involved are approaching this based on their experience with HIV. I know this will make everyone angry and frustrated because we're perfectly happy with what our heroes are doing, but they (the NIH) are still looking for convergence on negative and positive samples, where the different labs involved get consistent results on even ONE of each, using their different methods. They need a higher degree of convergence than the BWG labs have achieved so far, so this is yet another step in that research -- to collect 50 patient samples of sufficient quantity (I think he said 100 mL) for further testing by the different labs.
They are continuing to work on this to develop two things:
The first is a high-throughput screening test that is very sensitive, as they now have for the HIVs. However, highly sensitive tests run the risk of identifying false positives (inaccurate positive test results). But the value of a highly sensitive test, even if it yields some percentage of false positives, is that ideally it catches a very, very large percentage of people who actually are positive and doesn't miss anyone (i.e., give false negative results).
The second is a highly specific test -- one that is extremely accurate at identifying the presence of infection and rules out anyone with a false positive result from the initial screening test. In the best of all worlds, the highly specific confirmatory test would also eventually give relatively quick results, on the order of a few days...
None of the above is new to us. But I thought it was worth going over again, just to reiterate what they (the NIH/BWG) are searching for and what they've all been saying they need in order to do further disease-causality research, as well as the epidemiological research to identify prevalence of the infection(s).
They are looking for patients who have already been tested in the belief these will be the "sickest of the sick." The thinking among the retrovirologists is based on what worked to find HIV and nail down the methods of testing for it. The idea is that patients who have already sought testing, either from a private lab or by volunteering to participate in other studies, are likely to be a patient group that is really, really sick (my words) with ME/CFS, however it's defined, and so more likely to be infected with XMRV/friends than potential participants identified through other methods. They are NOT, however, ruling out obtaining samples from patients who haven't been tested previously (more on that later), but prefer to collect the samples from people who have already selected themselves for testing, independently from the results. He said that they are NOT looking to compare previous test results to what comes out of the tests done from this effort. He said the preference for previously tested participants is based on the characteristics of this group of patients, rather than their previous test results.
In fact, he was upset when I said that some of us were very concerned that the purpose of this study is to invalidate previous test results from our heroes at WPI, NCI-Frederick, FDA, NIH/Alter. He said that's not the purpose of seeking patients previously tested as negative or positive at all, that our hero(ine) labs are fully aware of this study, are participating in it and that the samples WILL be shared with them for the testing. (My thought -- this is actually kind of a nifty way to side-step the whole controversy/question of which diagnostic criteria will be used. More on this later, too.)
Another point I found interesting is that he said NIH did NOT write the announcement of this study, the CAA did. He said that any patient recruitment announcement from the NCI would have to be approved by the NIH IRB, which did NOT review and approve the CAA blurb. He said they approached CAA to make them aware of the study because the CAA has so many members and is supportive of continuing this research. (My sense here is the same one we've all had re: the new retrovirologists who are just getting into ME research, which is that they're clueless about the ME/CFS history and politics -- despite being highly experienced with obstreperous HIV patient groups.)
So, given that he was upset that we are concerned that this is an attempt to undermine and/or invalidate the WPI and our other heroes, and he said that our heroes are willingly participating in this (obviously, they wouldn't, if they were concerned that it was a conspiracy to undermine them), I am REALLY wondering HOW this statement got into the announcement: "The researchers are specifically trying to reach individuals who have already been tested for XMRV so they can compare the results of their new tests with the results obtained using other tests."
MY question is, if the reason for wanting patients who have already sought out testing is because they are likely to be really sick, then how the hell did that statement get into the announcement and WHAT is the CAA up to with it??? OR, are there others involved in this study or higher up in management who DO have this agenda and communicated it to the CAA? (Obviously, I believed Dr. Maldarelli's explanation of why they'd prefer to have patients who have already sought out testing, so, Gerwyn, I'm fully prepared for you to call me "naive," among other names.)
So, that's the most important stuff I wanted to share about the conversation. I have additional thoughts/speculations I'll post next.